Pharmacokinetic (PK)/Pharmacodynamic (PD), Study of Single-dose Subcutaneous CDP6038 in Healthy Japanese Male Subjects

UCB

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Biological: CDP6038; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01262794

RA0074

2010-022543-38 (EudraCT Number)

Details and patient eligibility

About

To evaluate the safety and tolerability of CDP6038 following single dose subcutaneous (sc) administration of CDP6038 to Japanese subjects.

To evaluate the Pharmacokinetics of CDP6038 following single dose sc administration of CDP6038 to Japanese subjects

Enrollment: 20 patients

Sex: Male

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Japanese volunteers

Exclusion criteria

• Subject has participated in any other clinical drug study (including a biologic product or a medical device) within 5 PK half-lives or 3 months (whichever is longer) prior to Screening, or the subject is currently participating in another clinical study.
• Subject is not healthy (eg, taking any drug treatments, any psychological or emotional problems, a drug/alcohol abuse or a having a history of drug/alcohol abuse, having abnormal safety parameters)

Trial design

20 participants in 5 patient groups, including a placebo group

CDP6038 0.3 mg/kg

Experimental group

Treatment:

Biological: CDP6038

CDP6038 1 mg/kg

Experimental group

Treatment:

Biological: CDP6038

CDP6038 3 mg/kg

Experimental group

Treatment:

Biological: CDP6038

CDP6038 6 mg/kg

Experimental group

Treatment:

Biological: CDP6038

Placebo

Placebo Comparator group

Treatment:

Biological: Placebo